Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lapatinib/nab-Paclitaxel — DRUG
  This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib (TYKERB) in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously on Day 1, 8, 15, every 28 days (q28) days plus lapatinib (1000 mg once daily on a continuous basis).

Study Details

This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects were to be enrolled in the study. Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib (1000 mg once daily). Subjects were to receive treatment until disease progression or withdrawal from the study. The primary objective of this study was to evaluate overall tumor response rate of lapatinib in combination with nab-paclitaxel administered in women with ErbB2 overexpressing MBC who received no chemotherapeutic regimen in the metastatic setting. Secondary objectives included progression-free survival, overall survival, duration of response, time to response and time to progression and safety. Safety and efficacy assessments were to be performed at 8 and 12 week intervals, and at the end of treatment. Subject: Metastatic Breast Cancer, ErbB2, First-line therapy, Lapatinib, Nab-paclitaxel

Key Dates

Start date

Jul 2, 2008

Status verified

Mar 2019

Primary completion

Jan 5, 2011

Completion

Jan 3, 2018

Study Design

Enrollment

60 participants (actual)

Primary purpose

TREATMENT

Arms

• Experimental: Single Arm
  Single arm combination therapy of Lap and NabPaclitaxel combination

Primary Outcome Measure

Overall Tumor Response (OR) [ Time Frame: Start of treatment to disease progression or death or discontinuation from study or at least 28 days after last dose (up to Week 131) ]

Locations (13)

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